Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported August 18, 2021
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Baxter Healthcare Corporation recalled Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the … - a critical-severity action.
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the … was recalled by Baxter Healthcare Corporation in August 18, 2021. Reason: System errors were noted following changes the customers implemented to the configuration of their network an…. Check the official notice for the remedy. Verify recall #Z-2110-2021 with the FDA Devices before acting.
The recall
Baxter Healthcare Corporation issued this critical-severity FDA Devices recall-System errors were noted following changes the customers implemented to the configuration of their network an….
- Critical
- severity level
- 130K units
- affected scope
- Class I
- classification
- August 18, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2110-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2110-2021) was formally reported on August 18, 2021, with the manufacturer initiating the action on June 4, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Baxter Healthcare Corporation is listed as the recalling firm, operating out of Deerfield, IL. Federal records list the affected scope as 130135 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectiv… Distribution data in the federal record shows the product reached: United States (including Puerto Rico), Canada, Bahamas, Bermuda, Guyana, and Trinidad and Tobago.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
130135 units
Related Recalls
6
3 from same agency
Product description
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Reason for recall
System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2110-2021 |
| Date reported | August 18, 2021 |
| Date initiated | June 4, 2021 |
| Recalling firm | Baxter Healthcare Corporation |
| Firm location | Deerfield, IL |
| Affected scope | 130135 units |
| Distribution | United States (including Puerto Rico), Canada, Bahamas, Bermuda, Guyana, and Trinidad and Tobago. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2110-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.. Recalled by Baxter Healthcare Corporation. Units affected: 130135 units.
Why was this product recalled? ▼
System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 18, 2021. Severity: Critical. Recall number: Z-2110-2021.
Where was the recalled product distributed? ▼
Distribution: United States (including Puerto Rico), Canada, Bahamas, Bermuda, Guyana, and Trinidad and Tobago..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2110-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 18, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.